48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease (NCT04002583) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
United States20 participantsStarted 2020-02-19
Plain-language summary
Researchers are trying to determine the frequency of seizures and epilepsy in patients with Early-onset Alzheimer's disease (EOAD) using a 48-hour computer assisted ambulatory electroencephalogram.
Who can participate
Age range40 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for EOAD patients will be recruited from the LEADS trial with the following:
* 40 to 64 years of age
* Meets NIA-AA criteria for mild cognitive impairment (MCI) due to AD or probable AD dementia.
* Have a global CDR score of ≤ 1.0
* Have capacity to provide informed consent (ICF) or has a legal authorized representative or guardian who provides IC.
* Amyloid positive status (PET scan with evidence of elevated amyloid)
* Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, and caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI.
* Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
* Fluent in English.
Exclusion Criteria:
* Meets core clinical criteria for non-AD dementia.
* Two or more first degree relatives with a history of EOAD suggestive of autosomal dominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2 have been excluded.
* Known mutation in an ADAD gene (APP, PSEN1, PSEN2) or other autosomal dominant genes associated w…
What they're measuring
1
Electrographic seizures: Number of subjects with electrographic seizures